PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

• K Number: K012794
• Device Name: PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
• Manufacturer: PRIME DENTAL MANUFACTURING, INC.
• Date Cleared: 2001-11-05 ( 76 days)
• Product Code: EBF , EBC
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA I Time-Dome Chomical Casin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) summary for "Prime-Dent Chemical Cure Pit & Fissure Sealant" (K012794) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a letter from the FDA to the manufacturer, indicating that the device has been found substantially equivalent to a predicate device and can be marketed. It refers to the device's indications for use but does not delve into the detailed performance data that would typically be found in a study report.

Therefore, I cannot provide the requested table and study details based on the given information.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.